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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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Regulatory Convergence

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US medical device regulators have released a newly updated guidance document on the submission of electronic copies of device submissions under a program known as "eCopy," expanding the guidance by several pages to include "clarifications" based on the agency's "experience to date with the program."

The eCopy program was brought into law under Section 745A9b) of the Food and Drug Administration Safety and Innovation Act (FDASIA).

As explained by FDA, "An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and submitted on a CD, DVD, or in another electronic media format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the complete original paper submission." The system is currently voluntary.

FDASIA&nbsp;states that the system will come into effect 24 months after FDA issues final guidance to industry, and will apply to all devices submitted to the agency under sections 510(k), 513(f)(2)(A), 515(c), 515 (d), 515(f), 520(g), 520(m), or 564 of the&nbsp;Federal Food, Drug and Cosmetic Act. In addition, certain pre-submissions and any biological device submitted under Section 351 of the&nbsp;Public Health Service Act (PHSA)&nbsp;will also be required to submit application using the eCopy Program.

Guidance

FDASIA&nbsp;established two requirements for the eCopy guidance: It must provide standards for what is required to be submitted using the electronic copy, and must establish criteria and waivers for exemptions from the program.

FDA first published draft guidance in October 2012 on eCopy submissions, and later finalized the same in January 2013. The guidance established three types of applications exempt from its eCopy mandate: Compassionate use investigational device exemption (IDE) submissions, emergency use IDE submissions and emergency use authorizations (EUAs). No other exemptions will be given due to the&nbsp;low cost and widespread availability&nbsp;of eCopy software, explained FDA.

The remainder of the guidance was an extensive, if not overly specific, step-by-step explanation of how the e-copies should be submitted to FDA correctly.

Regulators: The Philosophy Behind eCopy

Which, to hear regulators explain it, makes complete sense. In comments made at the October 2012 RAPS: The Regulatory Convergence conference in Seattle, WA, Barbara Zimmerman, deputy director for premarket program management at FDA's Office of Device Evaluation (ODE), said the program was intended to reduce the amount of time FDA needs to reformat information to enter it into its databases.

In addition, the system should also make the review of applications more consistent and accurate, she said, reflecting the agency's ability to better keep track of information about the submissions it has received and reviewed.

"DocMan"-CDRH's Document Manager, a system that will create a repository of information for each application-will also radically change the way FDA converses with sponsors, predicted Zimmerman. Under the DocMan system, all review memos, checklists, correspondence, emails and approval packages will be automatically be copied to a unique email address. In other words, sponsors can rest easy knowing their emails are easily accessible to a reviewer and are not lost in a sea of unread emails, said Zimmerman.

Updated Guidance: Clarifying Submission Standards

And to ensure good data, you need good submissions. Hence, the iterations of the eCopy guidance, the latest of which FDA published on 10 October 2013.

The updated guidance reflects FDA's experience through the first several months of the program, and includes new questions such as:

Are there any issues to consider when choosing the eCopy media? (Recognize that some flash drives have pre-loaded files that may lead to FDA's file loading process to fail.)

How do you know if an eCopy meets the technical standards before you sent it to FDA? (There are free eSubmitter-eCopies tools available on FDA's website, which the agency "strongly encourages" applicants to use. A quick reference guide also exists.)

Are standards different depending on if one party submits a document on behalf of another? (No. "The eCopy requirements are the same regardless of who is submitting the eCopy.)

Can alternate submission formats be used? (Yes, so long as they can be submitted through FDA's Electronic Submissions Gateway or through CBER's Document Control Center if it is physical media containing digital files.)

The guidance also contains an extensive list of new technical standards for eCopies, including the "basic steps for developing an eCopy." FDA lists a number of recommendations for filing, including how files should be submitted and labeled in the submission process, as well as the attributes those files should have.

Among the more common suggestions:

Don't password protect a file.

Don't confuse hyperlinks and bookmarks with embedded attachments, the latter of which is not permitted by FDA.